The Impact of a Tobacco Control Intervention in African-American Families

Not Applicable

Completed

• Conditions: Environmental Tobacco Smoke Exposure; Tobacco Prevention; Tobacco Cessation
• Interventions: Behavioral: Healthy Lifestyle Behavior Choices; Behavioral: LifeSkills Training; Behavioral: NRT and Motivational Interviewing (MI)

• Registration Number: NCT01164306
• Lead Sponsor: Augusta University

Brief Summary

The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:

1. preventing tobacco initiation in youth

2. promoting anti-tobacco socialization in the home

3. decreasing environmental tobacco smoke exposure in children

4. promoting successful cessation in parent/guardian smokers.

Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.

Detailed Description

All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.

Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2012-05
• Study Completion: 2014-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 688

Inclusion Criteria

• child being of African-American ethnicity
• in a 4th grade classroom of randomized schools
• parent or guardian that 4th grade child resides with at least 50% of the time
• have access to a telephone or mobile phone

Exclusion Criteria

• not being a child of African-American ethnicity
• not being a parent or guardian that an eligible child lives with at least 50% of the time
• not having access to a telephone or cell phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Lifestyle Behaviors	Healthy Lifestyle Behavior Choices	-
LifeSkills training	LifeSkills Training	-
LifeSkills training	NRT and Motivational Interviewing (MI)	-

Primary Outcome Measures

Name	Time	Method
Primary prevention of tobacco use in youth	Year 4	Self-report and salivary cotinine is assessed to measure this outcome.

Secondary Outcome Measures

Name	Time	Method
Smoking cessation in parents/guardians	Year 4

Trial Locations

Locations (1)

Georgia Health Sciences University; 🇺🇸 Augusta, Georgia, United States